Redesigning the Surgical Pathway (PROMoTE)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorSunnybrook Health Sciences Centre

About this trial

Cognitive complications, that is problems with thinking and memory, are incredibly common after surgery, occurring in 10-50% of all older surgical patients. These complications can take different forms, but one of the most common is postoperative delirium (POD), a short-term state of confusion. In addition to being stressful for patients and their families, POD is linked to longer hospital stays, increased costs, higher mortality rates and other problems after surgery. Despite this, POD is often not recognized by doctors and there are currently no effective medications to treat POD. However, simple strategies such as helping patients to sleep properly and remain hydrated, have been shown to help.

This study is testing if a delirium-reduction program will reduce postoperative delirium (POD) in older surgical patients. The investigators will first test memory and thought processes before surgery to find people who are most likely to develop POD. Once these people have been identified, they will be enrolled in a program which includes recommendations for their care team (e.g. surgeon, anesthesiologist, nurses) as well as educational materials for them and their family related to things that can be done to prevent delirium. By identifying at-risk patients and making sure that their doctors and caregivers are aware of how to prevent delirium, the investigators expect that this study will make surgery safer for older surgical patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥ 60 years old

Undergoing major elective surgery (e.g., intra-abdominal, retroperitoneal, major orthopedic) with an expected postoperative stay of at least 1 night

Evidence of cognitive impairment on baseline screening tests (i.e. any score < 90 on CBB or >10 on S-OMCT)

Disqualifiers

Patients undergoing cardiac surgery

Patients undergoing intracranial neurosurgery

Patients with known substance use disorder (verbally declared by patients)

Unlikely to comply with study assessment (e.g., no fixed address, without access to internet/computer/phone).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Multicomponent delirium-risk prevention bundle

    Other intervention

    This multidisciplinary intervention will introduce new practices including: 1. Direct-to-Patient Education Program 2. Directly informing anesthesia and surgery teams about high-risk patients by flagging their chart, and providing suggestions for POD mitigation 3. Flag charts as high risk for POD so that nursing staff in both the PACU and the wards are aware, facilitating implementation of CHASM interventions (i.e. evidence-based delirium prevention protocols). 4. Reinforce CHASM best practices with regular educational sessions for nurses.

Treatment groups

260 Participants
are divided into 2 treatment groups
Group A: Standard of CareNo intervention 0 interventions
Group B: InterventionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of POD before and after implementation of an institutional prospective diagnostic program.

POD evaluated by 3D-CAM and retrospectively using the CHART-DEL method

Time frame
twice daily on postoperative days 1-3, morning/late afternoon

Secondary outcomes

1

Delirium Severity

Assessed using CAM-S

Time frame
twice daily on postoperative days 1-3, morning/late afternoon
2

Hospital length of stay

Duration of hospital admission in days

Time frame
Until discharge, average of 1 week
3

Unit adherence rate to CHASM principles

Unit adherence rate to CHASM principles

Time frame
Until discharge, average of 1 week

Other outcomes

Sponsors and contacts

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